Abbott Advances Its Revolutionary Fully Bioabsorbable Drug Eluting Stent With Initiation of Next Phase of Clinical Trial
By Prne, Gaea News NetworkMonday, March 23, 2009
ABBOTT PARK, Illinois - Abbott (NYSE: ABT) today announced the initiation of the next phase of
the ABSORB clinical trial to evaluate the safety and performance of the
company’s fully bioabsorbable drug eluting coronary stent. This second phase
of the ABSORB clinical trial will enroll approximately 80 patients at 10
centers in Europe, Australia and New Zealand, and will incorporate device
enhancements designed to improve deliverability and vessel support. The first
patient was enrolled into the second stage of the ABSORB clinical trial at
Onze Lieve Vrouw Ziekenhuis Hospital in Aalst, Belgium, by Bernard De Bruyne,
M.D., Ph.D.
“Interventional cardiology has come a long way. It started with balloon
angioplasty, which evolved into bare metal stents and then drug eluting metal
stents were created,” said Patrick W. Serruys, M.D., Ph.D., professor of
interventional cardiology at the Thoraxcentre, Erasmus University Hospital,
Rotterdam, and principal investigator of the ABSORB trial. “Now we have the
fourth revolution in interventional cardiology technology, and patient
outcomes from the first stage of ABSORB clearly show that bioabsorbable
devices are the future of coronary artery disease treatment.”
Results from the first stage of the ABSORB trial with 30 patients
demonstrated that Abbott’s bioabsorbable everolimus eluting stent
successfully treated coronary artery disease, and that at two years, the
treated vessel was able to expand and contract, without being restricted by a
permanent implant - indicating that the device was absorbed. In addition,
there were no cases of thrombosis (blood clot formation) out to two years of
follow-up, and no new major adverse cardiac events (MACE) between six months
and two years, with the bioabsorbable device demonstrating a MACE rate of 3.6
percent (one patient) at two years. MACE is a composite clinical measure of
safety and efficacy outcomes, defined as any event that resulted in
re-treatment of the treated artery lesion (ischemia-driven target lesion
revascularization), heart attack (myocardial infarction) or cardiac death.
“Based on the strong clinical outcomes from the first stage of Abbott’s
bioabsorbable device trial, interventional cardiologists have been eager to
enroll their patients into the second stage of the trial,” said John
Ormiston, M.D., medical director at Mercy Hospital in Auckland, New Zealand,
and co-principal investigator in the ABSORB trial. “If the bioabsorbable
stent continues to perform well in this trial and subsequent larger trials
with more complex narrowings, bioabsorbable device technology may become the
new standard of care for patients with coronary artery disease.”
Abbott is the only company with long-term clinical data (out to two
years) evaluating the safety and performance of a fully bioabsorbable drug
eluting coronary stent. Abbott’s bioabsorbable everolimus eluting coronary
device is made of polylactic acid, a proven biocompatible material that is
commonly used in medical implants such as absorbable sutures. As with a
metallic stent, Abbott’s bioabsorbable device is designed to restore blood
flow by propping a clogged vessel open, and to provide support until the
blood vessel heals. Unlike a metallic stent, however, a bioabsorbable device
is designed to be slowly metabolized by the body and completely absorbed over
time.
“Abbott has been on the front lines of innovation in stent technology,
and the fully bioabsorbable device is on track to become a clinical reality
for patients,” said John M. Capek, Ph.D., executive vice president, Medical
Devices, Abbott. “Abbott is the furthest ahead in its clinical programs to
bring a bioabsorbable drug eluting device to patients, and the company is
committed to continuing to invest in this promising technology and to bring
it to market as soon as possible.”
The ABSORB trial reinforces Abbott’s commitment to research and develop
innovative devices in vascular care. Abbott’s robust vascular research
program includes clinical trials in peripheral artery disease, carotid artery
disease, and coronary artery disease. Key products in the vascular pipeline
include: the Omnilink Elite(TM) Peripheral Stent System; the EMBOSHIELD
NAV6(TM) Embolic Protection System for carotid stenting; and the XIENCE
PRIME(TM) Everolimus Eluting Coronary Stent System, which builds upon the
proven performance of Abbott’s market-leading XIENCE V(R) Everolimus Eluting
Coronary Stent System.
Onmilink Elite, EMBOSHIELD NAV6 and XIENCE PRIME are investigational
devices and are not available for sale.
About the ABSORB Clinical Trial
The ABSORB trial is a prospective, non-randomized (open label), two-phase
study designed to enroll approximately 110 patients in Australia, Belgium,
Denmark, France, the Netherlands, New Zealand, Poland and Switzerland. Key
endpoints of the study include assessments of safety - MACE and stent
thrombosis rates - at 30 days; six, nine, 12 and 18 months; and two years,
with additional annual clinical follow-up for up to five years, as well as an
assessment of the acute performance of the bioabsorbable drug eluting stent,
including successful deployment of the system. Other key endpoints of the
study include imaging assessments by angiography, intravascular ultrasound
(IVUS), optical coherence tomography (OCT), and other state-of-the-art
invasive and non-invasive imaging modalities at six months, one year and two
years.
Abbott’s bioabsorbable drug eluting device delivers everolimus, a drug
that inhibits tissue proliferation. The device props open and supports a
narrowed blood vessel until the vessel heals, restoring blood flow, and is
absorbed over time by the vascular tissue as part of the body’s normal
processes. If clinical results are positive, bioabsorbable drug eluting
stents could eventually offer an alternative to the metallic drug eluting
stents available to patients today.
About XIENCE V
Abbott’s market-leading XIENCE V drug eluting stent was approved by the
U.S. Food and Drug Administration and launched in July 2008, and was launched
in Europe and other international markets in October 2006. XIENCE V is an
investigational device in Japan and is currently under review by Japan’s
Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical
Devices Agency.
Additional information about XIENCE V, including important safety and
effectiveness information, is available online at www.xiencev.com.
Everolimus, developed by Novartis Pharma AG, is a proliferation signal
inhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on its
drug eluting stents. Everolimus has been shown to inhibit in-stent neointimal
growth in the coronary vessels following stent implantation, due to its
anti-proliferative properties.
About Abbott Vascular
Abbott Vascular, a division of Abbott, is one of the world’s leading
vascular care businesses. Abbott Vascular is uniquely focused on advancing
the treatment of vascular disease and improving patient care by combining the
latest medical device innovations with world-class pharmaceuticals, investing
in research and development, and advancing medicine through training and
education. Headquartered in Northern California, Abbott Vascular offers a
comprehensive portfolio of vessel closure, endovascular and coronary
products.
About Abbott
Abbott is a global, broad-based health care company devoted to the
discovery, development, manufacture and marketing of pharmaceuticals and
medical products, including nutritionals, devices and diagnostics. The
company employs more than 72,000 people and markets its products in more than
130 countries.
Abbott’s news releases and other information are available on the
company’s Web site at www.abbott.com.
Source: Abbott
Media, Jonathon Hamilton, +1-408-845-3491, or Jennie Kim, +1-408-845-1755, or Financial, Tina Ventura, +1-847-935-9390, all of Abbott
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